RAPID MEDICAL INC.
Registration 3015531723FEI 3015531723Southlake, TX
Owner/operator: Rapid Medical Inc.
- Complaint File Establishment per 21 CFR 820.198
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
90days left in the window
The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 17
- Added, last 12 months
- 6
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 17
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| NRY | Tigertriever 13 Ultra (Micro) Revascularization DeviceCatheter, Thrombus RetrieverAdded Aug 30, 2026 | Class 2 | 21 CFR 870.1250 | K260617 |
| NRY | Tigertriever 13 Revascularization DeviceCatheter, Thrombus Retriever | Class 2 | 21 CFR 870.1250 | K230429 |
| NRY | Tigertriever 25 Revascularization DeviceCatheter, Thrombus RetrieverAdded Mar 15, 2026 | Class 2 | 21 CFR 870.1250 | K253062 |
| NRY | Tigertriever 17 Ultra Revascularization DeviceCatheter, Thrombus RetrieverAdded Nov 16, 2025 | Class 2 | 21 CFR 870.1250 | K251603 |
| NRY | Tigertriever 13Catheter, Thrombus Retriever | Class 2 | 21 CFR 870.1250 | K220808 |
| NRY | TigertrieverCatheter, Thrombus Retriever | Class 2 | 21 CFR 870.1250 | K203592 |
| HCG | Numen Coil Embolization SystemDevice, Neurovascular Embolization | Class 2 | 21 CFR 882.5950 | K203625 |
| KRD | Numen Coil Embolization SystemDevice, Vascular, For Promoting Embolization | Class 2 | 21 CFR 870.3300 | K203625 |
| MOF | DriveWire 14 LRGuide, Wire, Catheter, Neurovasculature | Class 2 | 21 CFR 870.1330 | K200374 |
| MOF | Drivewire 35 GuidewireGuide, Wire, Catheter, NeurovasculatureAdded Jul 19, 2026 | Class 2 | 21 CFR 870.1330 | K254006 |
| MOF | Drivewire 24 GuidewireGuide, Wire, Catheter, Neurovasculature | Class 2 | 21 CFR 870.1330 | K233791 |
| PUU | ComaneciTemporary Coil Embolization Assist Device | Class 2 | 21 CFR 882.5955 | DEN170064 |
and 5 more on your full dossier
What changed
- Aug 30, 2026Listing added: NRY — Tigertriever 13 Ultra (Micro) Revascularization Device (K260617)
- Mar 15, 2026Listing added: NRY — Tigertriever 25 Revascularization Device (K253062)
- Nov 16, 2025Listing added: NRY — Tigertriever 17 Ultra Revascularization Device (K251603)
- Jul 19, 2026Listing added: MOF — Drivewire 35 Guidewire (K254006)
- Sep 20, 2026Listing added: DQX — Hyperdrive 35 Guidewire (K253146)
- Jul 19, 2026Listing added: DQX — Drivewire 35 Guidewire (K254006)